medical Class II Updated 2025-01-01

MEDLINE INDUSTRIES, LP - Northfield recalls Medline brand, medical procedure convenience kits, labeled a

Recalled Product

Medline brand, medical procedure convenience kits, labeled as: 1) SINUS CDS-1, SKU CDS982901F; 2) NASAL PACK, SKU DYNJ17493G; 3) FESS PACK-POB, SKU DYNJ33520A; 4) SINUS PACK, SKU DYNJ44845G; 5) SINUS PACK, SKU DYNJ48330B; 6) ENT PACK, SKU DYNJ50572; 7) ENT PACK, SKU DYNJ53573A; 8) ENT HUTCH, SKU DYNJ58856A; 9) PACK NASAL, SKU DYNJ60111A; 10) PACK NASAL, SKU DYNJ60111B; 11) ENT CUSTOM PACK, SKU DYNJ63052C; 12) ENT PACK, SKU DYNJ64256D; 13) FESS/SEPTOPLASTY PACK, SKU DYNJ64509B; 14) SINUS ENDOSCOPY PACK, SKU DYNJ65644; 15) ACOUSTICS SHSC-LF, SKU DYNJ66749; 16) TRANSPHENOIDAL PACK, SKU DYNJ67423A; 17) TRANSPHENOIDAL PACK, SKU DYNJ67423B; 18) ENT PACK, SKU DYNJ68102B; 19) E N T PACK, SKU DYNJ80526B; 20) NASAL PACK, SKU DYNJ81280; 21) ENT FESS PACK, SKU DYNJ81420A; 22) HEAD AND NECK PACK, SKU DYNJ81934; 23) HEAD AND NECK PACK - 51597, SKU DYNJ81934A; 24) HEAD AND NECK ENT PACK, SKU DYNJ83679A; 25) HEAD NECK PACK HC, SKU DYNJ84270; 26) TRANSPHENOIDAL PACK-LF, SKU DYNJ85422; 27) NASAL SEPTAL, SKU DYNJ901299A; 28) NASAL SEPTAL, SKU DYNJ901299B; 29) PACK TRANSPHENOIDAL, SKU DYNJ905685D; 30) SEPTOPLASTY, SKU DYNJ906474C; 31) LEFORTE MANDIBLE, SKU DYNJ906839A; 32) NASAL MHS, SKU DYNJ908545A; 33) NASAL MHS, SKU DYNJ908545B; 34) ENT, SKU DYNJ909128A; 35) ENT, SKU DYNJ909128C; 36) ENT, SKU DYNJ909128D; 37) ENT, SKU DYNJ909128F; 38) SINUS PACK, SKU DYNJ909370

Hazard / Issue

Surgical Patties & Surgical Strips in specific lots of Custom Convenience Kits were found to contain higher-than-expected levels of endotoxin within the raw material used to produce sterile Codman Surgical Patties and Strips that may have resulted in out-of-specification levels of endotoxin in those finished goods

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: CDS982901F, 10889942216970 (each), 40889942216971 (case), Lot Numbers: 23HBQ152; UDI-DI: DYNJ17493G, 10195327224424 (each), 40195327224425 (case), Lot Numbers: 23GBW775; UDI-DI: DYNJ33520A, 10884389851333 (each), 40884389851334 (case), Lot Numbers: 23HDB834; UDI-DI: DYNJ44845G, 10889942712311 (each), 40889942712312 (case), Lot Numbers: 23HBF195; UDI-DI: DYNJ48330B, 10195327113506 (each), 40195327113507 (case), Lot Numbers: 23HBO622; UDI-DI: DYNJ50572, 10889942008476 (each), 40889942008477 (case), Lot Numbers: 23GBR940; UDI-DI: DYNJ53573A, 10193489201635 (each), 40193489201636 (case), Lot Numbers: 23GBS356; UDI-DI: DYNJ58856A, 10193489750263 (each), 40193489750264 (case), Lot Numbers: 23HBO870; UDI-DI: DYNJ60111A, 10193489246995 (each), 40193489246996 (case), Lot Numbers: 21JMB783 21HMF433 21GMD178 21FMC923 20IMB575; UDI-DI: DYNJ60111B, 10195327527617 (each), 40195327527618 (case), Lot Numbers: 24HMC974 24GMA899 24FMB079 24EMC108 24DMD791 24CMG320; UDI-DI: DYNJ63052C, 10195327101312 (each), 40195327101313 (case), Lot Numbers: 22KME394 22KMA630 22JMD852 22GMG160 22EMG974 22DMF954 22CMC565; UDI-DI: DYNJ64256D, 10195327452773 (each), 40195327452774 (case), Lot Numbers: 23HBA766; UDI-DI: DYNJ64509B, 10195327323745 (each), 40195327323746 (case), Lot Numbers: 23HBC092; UDI-DI: DYNJ65644, 10193489283204 (each), 40193489283205 (case), Lot Numbers: 23HBA753; UDI-DI: DYNJ66749, 10193489375947 (each), 40193489375948 (case), Lot Numbers: 21ABT938 21ABO570 20JBS998 20HBM389; UDI-DI: DYNJ67423A, 10195327163402 (each), 40195327163403 (case), Lot Numbers: 24DLA092 24BLA235 23KLA058 23ILB043 23ILA503 23HLB296 23HLB011 23FLA068 23DLA463 23DLA185 23BLA617 22LLA582 22KLA652 22HLA029 22GLA884; UDI-DI: DYNJ67423B, 10195327686871 (each), 40195327686872 (case), Lot Numbers: 24GLB018 24FLA258 24ELA763 24DLA759; UDI-DI: DYNJ68102B, 10195327699369 (each), 40195327699360 (case), Lot Numbers: 24IBB348 24GBB791 24EBA114; UDI-DI: DYNJ80526B, 10195327211059 (each), 40195327211050 (case), Lot Numbers: 23HBF568; UDI-DI: DYNJ81280, 10195327102968 (each), 40195327102969 (case), Lot Numbers: 22HMF910; UDI-DI: DYNJ81420A, 10195327322601 (each), 40195327322602 (case), Lot Numbers: 24CBL416 23LBK136 23IBR308 23HBD265 23GBJ044 23FBK113 23EBN716 23BBQ143; UDI-DI: DYNJ81934, 10195327156817 (each), 40195327156818 (case), Lot Numbers: 23EBG024 23BBC727 22JBJ632 22HBH399; UDI-DI: DYNJ81934A, 10195327413019 (each), 40195327413010 (case), Lot Numbers: 24DBK564 24DBB486 24CBG998 24BBV700 24ABD320 23HBO084 23GBG012; UDI-DI: DYNJ83679A, 10195327459727 (each), 40195327459728 (case), Lot Numbers: 24HBP441 24GBF665 24BBO428 23LBS373 23JBD663 23IBN314; UDI-DI: DYNJ84270, 10195327349103 (each), 40195327349104 (case), Lot Numbers: 23GBC274; UDI-DI: DYNJ85422, 10195327499716 (each), 40195327499717 (case), Lot Numbers: 24FDA925 24ADB100; UDI-DI: DYNJ901299A, 10889942010349 (each), 40889942010340 (case), Lot Numbers: 21FBC250 20JBO761 20IBH831 20FBM501; UDI-DI: DYNJ901299B, 10193489923384 (each), 40193489923385 (case), Lot Numbers: 22FBU440 22OBC118 22OBC120 22ABA377 21JBJ197 21IBM868 21GBO441; UDI-DI: DYNJ905685D, 10198459024139 (each), 40198459024130 (case), Lot Numbers: 24IDB382; UDI-DI: DYNJ906474C, 10195327221355 (each), 40195327221356 (case), Lot Numbers: 24HDA228 24EDA811 24DDB542 23LDB493 23GDA771 23DDA732 22IDB976; UDI-DI: DYNJ906839A, 10195327092528 (each), 40195327092529 (case), Lot Numbers: 22JMB394; UDI-DI: DYNJ908545A, 10195327384166 (each), 40195327384167 (case), Lot Numbers: 23JBV681; UDI-DI: DYNJ908545B, 10195327593124 (each), 40195327593125 (case), Lot Numbers: 24HBI988 24FBS776 24FBA297 24ABT058; UDI-DI: DYNJ909128A, 10195327326739 (each), 40195327326730 (case), Lot Numbers: 23EBD903 23DBD851; UDI-DI: DYNJ909128C, 10195327458416 (each), 40195327458417 (case), Lot Numbers: 23JBO251 23HBI313; UDI-DI: DYNJ909128D, 10195327516321 (each), 40195327516322 (case), Lot Numbers: 24EBC023 24CBK211 24BBM816 24ABR742 23LBQ695 23LBM416; UDI-DI: DYNJ909128F, 10198459055256 (each), 40198459055257 (case), Lot Numbers: 24HBV054 24GBN495; UDI-DI: DYNJ909370, 10195327319038 (each), 40195327319039 (case), Lot Numbers: 24BMA818 24AMG256 23LMF420 23LMB722 23LMA458 23CME287;
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